Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

Purpose

The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.

Condition

  • Chronic Hepatitis B

Eligibility

Eligible Ages
Between 2 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Males and non-pregnant, non-lactating females - Weight at screening as follows: - Cohort 1 = ≥ 35 kg (≥ 77 lbs) - Cohort 2 Group 1 = ≥ 25 kg (≥ 55 lbs) - Cohort 2 Group 2 = ≥ 14 kg to < 25 kg (≥ 30 lbs to <55 lbs) - Cohort 2 Group 3 = ≥ 10 kg to < 14 kg (≥ 22 lbs to < 30 lbs) or - 14 kg to < 25 kg (≥ 30 lbs to < 55 lbs) - Willing and able to provide written informed consent/assent (child and parent/legal guardian) - Documented evidence of CHB (eg, HBsAg-positive for ≥ 6 months) - HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following: - Screening HBV DNA ≥ 2 × 10^4 IU/mL - Screening serum ALT > 45 U/L (> 1.5 × ULN: 30 U/L) and ≤ 10 × ULN (by central laboratory range) - Treatment-naive or treatment-experienced will be eligible for enrollment. - Estimated creatinine clearance (CLCr) ≥ 80 mL/min/1.73m^2 (using the Schwartz formula) - Normal ECG

Exclusion Criteria

  • Females who are pregnant or breastfeeding - Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study. - Coinfection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV) - Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required) - Any history of, or current evidence of, clinical hepatic decompensation - Abnormal hematological and biochemical parameters - Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis) - Received solid organ or bone marrow transplant - Currently receiving therapy with immunomodulators (eg, corticosteroids), or immunosuppressants - Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator - Malignancy within the 5 years prior to screening. Individuals under evaluation for possible malignancy are not eligible. - Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TAF (Cohort 1) 		Participants (12 to < 18 years) weighing ≥ 35 kg will receive TAF 25 mg tablet for 24 weeks
  • Drug: TAF
    Administered orally once daily
Placebo Comparator
Placebo (Cohort 1) 		Participants (12 to < 18 years) weighing ≥ 35 kg will receive placebo tablet for 24 weeks
  • Drug: Placebo
    Administered orally once daily
Experimental
TAF (Cohort 2 Group 1) 		Participants (6 to < 12 years) weighing ≥ 25 kg will receive TAF 25 mg tablet for 24 weeks
  • Drug: TAF
    Administered orally once daily
Experimental
TAF (Cohort 2 Group 2) 		Participants (6 to < 12 years) weighing ≥ 14 kg to < 25 kg will receive TAF 15 mg oral granules for 24 weeks
  • Drug: TAF
    Administered orally once daily
Experimental
TAF (Cohort 2 Group 3) 		Participants (2 to < 6 years) will receive TAF for 24 weeks as follows: weight ≥ 10 kg to < 14 kg (7.5 mg oral granules) weight ≥ 14 kg to < 25 kg (15 mg oral granules)
  • Drug: TAF
    Administered orally once daily
Placebo Comparator
Cohort 2 Placebo 		Participants will receive matching placebo of TAF (tablet or oral granules) for 24 weeks.
  • Drug: Placebo
    Administered orally once daily
Experimental
Open-Label TAF 		Following 24 weeks of blinded randomized treatment, participants will be eligible to participate in an open-label extension phase to receive TAF for an additional 216 weeks.
  • Drug: TAF
    Administered orally once daily

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Study Team
GS-US-320-1092@gilead.com